organix industries, inc. – FDA Warning Letter, Nov 25, 2019

The FDA issued a Warning Letter to Plant Organix in November 2019 after reviewing their website and social media. The FDA determined that Plant Organix was illegally marketing various CBD-containing products for human and animal consumption.

For human products, including "Classic Peanut Butter 300 mg CBD," "CBD Hibiscus Tea," and several CBD-infused gummies, oils, and balms, the FDA found them to be unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to lack of adequate directions for use. The claims made on the company's websites established their intended use as drugs for disease treatment or affecting bodily functions.

Furthermore, several human food products, such as "Banana Chips 300mg CBD" and "Classic Peanut Butter," were deemed adulterated under Section 402(a)(2)(C)(i) because they contained CBD, an unsafe food additive not generally recognized as safe (GRAS). Introducing these products into interstate commerce is a prohibited act under section 301(ll).

For animal products, "Hemp Pet Tinctures" and "Hemp Pet Treats" were identified as unapproved new animal drugs, unsafe under section 512(a), and adulterated under section 501(a)(5). The FDA